Product Details

Cayston

Aztreonam
75 mg/Vial
Lyophilized Powder for Inhalation Solution
Single-Use 2-mL Vial (Preservative-Free)

DIN/PIN/NPN

02329840

Manufacturer

Gilead Sciences Canada, Inc.

Formulary Listing Date

2018-06-29  

Unit Price

42.3989

Amount MOH Pays

42.3989

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

J01DF01

Interchangeable Products

NO  

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Anti-Infectives

Aztreonam

  • Brand(s): Cayston
  • Dosage Form/Strength: 75 mg/vial powder for solution

For the treatment of chronic infection with Pseudomonas aeruginosa (PsA) infection in patients with a diagnosis of Cystic Fibrosis who meet all the following criteria: 

  1. Patient has a documented diagnosis of cystic fibrosis;

  1. Patient has a chronic infection with Pseudomonas aeruginosa (PsA) that has been confirmed by 2 (two) positive sputum cultures taken at least 1 month apart that are both positive for PsA;

  1. the Patient’s clinical condition is deteriorating despite treatment with inhaled tobramycin;

  1. the Patient has moderate to severe impairment of lung function defined by baseline FEV1 less than 75% of predicted; AND

  1. the Patient is ≥ 6 years old.

Exclusion Criteria: Aztreonam (Cayston) will not be funded in the following circumstances.

  • Aztreonam will not be funded in combination with tobramycin inhalation

  • Aztreonam will not be funded for bronchiectasis indications outside of proven cystic fibrosis;

  • Aztreonam will not be funded outside of the cystic fibrosis population

  • Aztreonam will not be funded for patients with mild cystic fibrosis;

  • Aztreonam will not be funded for the purpose of convenience

Approved Dosage: The approved dosage for Aztreonam (Cayston) under the EAP is as follows:

Inhale 75 mg three times daily used in a repeated 28-day cycle that involves administration of aztreonam for 4 weeks of treatment followed by 4 weeks off aztreonam therapy.

Duration of Approval: 1 year

Renewals will be considered in patients who demonstrate ongoing response to therapy.

Duration of Approval: 1 year

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

View Monograph